Cerebral Blood Perfusion Changes After General Anesthesia for Craniotomy

NCT ID: NCT01642147

Last Updated: 2013-06-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-01-31

Brief Summary

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Few studies look into cerebral blood flow (CBF) changes during emergence from general anesthesia for craniotomy. The purpose of this study is to demonstrate CBF changes during emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation of jugular vein bulb and transcranial Doppler.

Detailed Description

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30 patients undergoing selective craniotomy (craniotomy group) for supratentorial brain tumor removal and 30 patients undergoing selective abdominal surgery (abdominal surgery group) are planned to be enrolled in the study. Mean blood flow velocity in middle cerebral artery (Vmca), mean arterial pressure (MAP), blood oxygen saturation of jugular vein bulb (SjvO2) (only measured in craniotomy group)and arterial CO2 partial pressure (PaCO2) will be measured before general anesthesia, at tracheal extubation, and 30,60, 90, 120 min after extubation in both groups.

Conditions

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Brain Neoplasms Surgery Hyperemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients undergoing craniotomy

Patients undergoing craniotomy who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.

Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed.

Group Type EXPERIMENTAL

Transcranial Doppler (TCD)

Intervention Type DEVICE

A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.

jugular venous bulb catheterization

Intervention Type PROCEDURE

After local anesthesia, a jugular venous bulb catheter(16G, manufactured by Arrow International Inc. USA) will be placed in the dominant side. The proper placement of the tip of the catheter in the jugular bulb will be confirmed later by a postoperative lateral skull X-ray. SjvO2 (blood sample will be drawn slowly at a speed of 2ml per minute) will be measured before anesthesia, at extubation, 30, 60, 90, and 120 min after extubation.

Tumor removal surgery under general anesthesia

Intervention Type PROCEDURE

Surgery types include total or subtotal removal of tumors.For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Radial artery catheterization

Intervention Type PROCEDURE

After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.

Patients undergoing abdominal surgery

Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler (TCD) measures,radial artery catheterization, and major abdominal surgery under general anesthesia will be performed.

Group Type ACTIVE_COMPARATOR

Transcranial Doppler (TCD)

Intervention Type DEVICE

A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.

Radial artery catheterization

Intervention Type PROCEDURE

After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.

Abdominal surgery under general anesthesia

Intervention Type PROCEDURE

For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Interventions

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Transcranial Doppler (TCD)

A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.

Intervention Type DEVICE

jugular venous bulb catheterization

After local anesthesia, a jugular venous bulb catheter(16G, manufactured by Arrow International Inc. USA) will be placed in the dominant side. The proper placement of the tip of the catheter in the jugular bulb will be confirmed later by a postoperative lateral skull X-ray. SjvO2 (blood sample will be drawn slowly at a speed of 2ml per minute) will be measured before anesthesia, at extubation, 30, 60, 90, and 120 min after extubation.

Intervention Type PROCEDURE

Tumor removal surgery under general anesthesia

Surgery types include total or subtotal removal of tumors.For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Intervention Type PROCEDURE

Radial artery catheterization

After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.

Intervention Type PROCEDURE

Abdominal surgery under general anesthesia

For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1\~2 µg/kg IV), and continuous vecuronium 50~70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.

Intervention Type PROCEDURE

Other Intervention Names

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TCD blood oxygen saturation of jugular vein bulb (SjvO2) craniotomy under general anesthesia

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesia (ASA) physical status I or II
* Scheduled for selective supratentorial tumor removal surgery or major abdominal surgery.

Exclusion Criteria

* Patients with evidence of systemic hypertension, intracranial hypertension, cerebrovascular diseases, other coexisting medical conditions likely to affect cerebral autoregulation.
* Preoperatively planned delayed tracheal extubation.
* Pregnant or nursing women
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Yu Yang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiao-Yu Yang, Master

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Shou-Jing Zhou, Master

Role: STUDY_CHAIR

Huashan Hospital

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Rasmussen M, Juul N, Christensen SM, Jonsdottir KY, Gyldensted C, Vestergaard-Poulsen P, Cold GE, Ostergaard L. Cerebral blood flow, blood volume, and mean transit time responses to propofol and indomethacin in peritumor and contralateral brain regions: perioperative perfusion-weighted magnetic resonance imaging in patients with brain tumors. Anesthesiology. 2010 Jan;112(1):50-6. doi: 10.1097/ALN.0b013e3181c38bd3.

Reference Type BACKGROUND
PMID: 19952725 (View on PubMed)

Randell T, Niskanen M. Management of physiological variables in neuroanaesthesia: maintaining homeostasis during intracranial surgery. Curr Opin Anaesthesiol. 2006 Oct;19(5):492-7. doi: 10.1097/01.aco.0000245273.92163.8e.

Reference Type BACKGROUND
PMID: 16960480 (View on PubMed)

Clavier N, Schurando P, Raggueneau JL, Payen DM. Continuous jugular bulb venous oxygen saturation validation and variations during intracranial aneurysm surgery. J Crit Care. 1997 Sep;12(3):112-9. doi: 10.1016/s0883-9441(97)90040-x.

Reference Type BACKGROUND
PMID: 9328850 (View on PubMed)

Bruder N, Pellissier D, Grillot P, Gouin F. Cerebral hyperemia during recovery from general anesthesia in neurosurgical patients. Anesth Analg. 2002 Mar;94(3):650-4; table of contents. doi: 10.1097/00000539-200203000-00031.

Reference Type BACKGROUND
PMID: 11867391 (View on PubMed)

Rijbroek A, Boellaard R, Vriens EM, Lammertsma AA, Rauwerda JA. Comparison of transcranial Doppler ultrasonography and positron emission tomography using a three-dimensional template of the middle cerebral artery. Neurol Res. 2009 Feb;31(1):52-9. doi: 10.1179/174313208X325191. Epub 2008 Jul 25.

Reference Type BACKGROUND
PMID: 18662500 (View on PubMed)

Sorond FA, Hollenberg NK, Panych LP, Fisher ND. Brain blood flow and velocity: correlations between magnetic resonance imaging and transcranial Doppler sonography. J Ultrasound Med. 2010 Jul;29(7):1017-22. doi: 10.7863/jum.2010.29.7.1017.

Reference Type BACKGROUND
PMID: 20587424 (View on PubMed)

Macmillan CS, Andrews PJ. Cerebrovenous oxygen saturation monitoring: practical considerations and clinical relevance. Intensive Care Med. 2000 Aug;26(8):1028-36. doi: 10.1007/s001340051315.

Reference Type BACKGROUND
PMID: 11030158 (View on PubMed)

Other Identifiers

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KY2012-183

Identifier Type: -

Identifier Source: org_study_id

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